Kornimate/medical-research-clean huggingface dataset:
exposure of children with asthma to household environmental tobacco smoke

Conditions: Asthma; Lung Diseases

Summary: to examine whether or not primary school-aged children with asthma from low-income households have lower household environmental tobacco smoke (ets) exposure than matched control children.

background: children with asthma are particularly vulnerable to environmental tobacco smoke (ets). however, despite this special vulnerability to ets, children with asthma are at least as likely to live in smoking households, as are healthy children. controversy exists, however, about whether or not the smoking members of households with children with asthma use specific strategies to reduce the harmful effects of their smoking on their children more than the smoking members of households of healthy children. design narrative: the case-control study examines whether or not primary school-aged children with asthma from low-income households have lower household ets exposure than matched control children. household ets exposure will be measured by both objective monitoring, specifically passive nicotine dosimeters and child cotinine assays (the primary hypothesis), and maternal-report (the secondary hypothesis). ninety children with physician diagnosed asthma and smoking mothers will be matched by age, gender, race/ethnicity, and other relevant variables to 90 healthy children. all children will be recruited from metro denver clinics providing services to low-income, underserved populations. the sample will contain equal numbers of african americans, hispanics, and whites. recruitment will target low-income populations due to their increased prevalence of, and associated morbidity from both asthma and tobacco smoking. specific household smoking behaviors, as reported by mothers, will be examined for association with household nicotine and child cotinine levels. finally, a set of carefully chosen measures will be examined in tertiary, exploratory analyses to help understand, clarify, and contextualize the observed results. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
an observational study of mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis (hortensia)

Conditions: Anemia

Summary: this observational study will evaluate the course of treatment, the efficacy on anemia and the safety of mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (esa). data will be collected from each patient for 12 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * chronic kidney disease, on dialysis for \> 3 months * treatment-naïve or previous treatment with esa * initiation of treatment with mircera for renal insufficiency associated anemia by decision of the treating physician exclusion criteria: * participation in a clinical trial * anemia due to an associated malignant pathology
visualisation of indocyanine green in primary and interval debulking for ovarian cancer

Conditions: Ovarian Cancer

Summary: visualise peritoneal lesions of epithelial ovarian cancer (eoc) in both primary and interval debulking surgery by using intravascular indocyanine green (icg) and near-infrared (nir) light. this trial wants to investigate whether icg can increase the visibility of peritoneal lesions and can differentiate between peritoneal implants and fibrosis.


Eligibility criteria:
inclusion criteria: 1. voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. 2. at least 18 years of age. 3. advanced stage epithelial ovarian cancer: figo stage iiib, iiic or iv. (for figo staging classification, please refer to appendix 7). 4. a biopsy or cytology confirming the presence of high-grade serous epithelial ovarian carcinoma 5. preoperative imaging (ct and/or mri), describing metastatic implants, as standard of care. exclusion criteria: 1. participant has a history of following diseases: 1. hyperthyroidism 2. autonomously functioning thyroid adenoma 2. participant has an allergy or hypersensitivity for one or more of the following components: 1. iodine (including potassium iodine) 2. indocyanine green 3. any disorder, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol. 4. any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the trial. 5. participation in an interventional trial with an investigational medicinal product (imp) or device during the surgery itself. 6. participant has a severe renal impairment (classified as renal function\<30 ml/min/1,73m2 according to ckd-epi). 7. participant utilises sodium bisulfite-containing heparin preparations during the day before surgery. for belgian registered drugs, this contains: 1. danaparoid (orgaran®) 2. other low-molecular weight heparins registered in belgium do not contain sodium bisulfite and are not an exclusion criterion. 8. participants requires thyroid scintigraphy utilising radioactive iodine one week after surgery. 9. a previous history of major intra-abdominal surgery with potentially major adhesions and/or distorted anatomy. 10. participants utilises one of the interacting drugs listed in the protocol
rtms and robotic gait training in patients with stroke

Conditions: Stroke

Summary: patients with stroke have demonstrated abnormal muscle tone and postural control ability which affect their ambulation, activity of daily living and confident. nowadays, utilizing repetitive transcranial magnetic stimulation (rtms) and robotic machines to assist walking training for stroke patients has been applied to clinic widely. while less studies have compared intervention efficacy for stroke patients between rtms and robotic training. this study aimed to compare effect of rtms and robotic training for lower-extremity function and gait in stroke patients.

this study will include subjects occurring stroke within 3 months. all groups will receive traditional rehabilitation. the subjects will be allocated randomly in three groups which are traditional rehabilitation (group a), robotic training (group b), and rtms (group c) respectively, with 35 people per group. the group b will be intervened 5 times per week and the group c will receive 10 times rtms intervention during 4 weeks. at post-intervention and eighth weeks after intervention, basic examination will be executed including basic information, history, mini-mental state examination, short -form 36, modified ashworth scale, fugl-meyer assessment, static and dynamic motion examination, ultrasound assessment and examination of cardiorespiratory. two-way mixed anova will be used to analyze the differences of three groups and times.

Eligibility criteria:
inclusion criteria: * first-time onset of stroke * reaching 20 years old and having clinical ct and mri diagnosis of stroke * hemiparesis with sitting ability after onset 3 months exclusion criteria: * brunnstrom stage over grade v * combined other neurological diseases (epilepsy, polyneuropathy, meniere's disease, vestibular neuritis, parkinson's disease, dementia, spinocerebellar ataxia) * lower extremity disease, included joint contracture, high muscle tone(mas more than 3), l/e fracture, joint replacement, long-term osteoarthritis pain * unstable vital sign * can't coordinate or sign consent plan form

Keywords: transcranial magnetic stimulation robotic gait training gait spasticity
mesenchymal stem cell-derived pleiotropic factor in treating poorly healed wounds of postoperative incision

Conditions: MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision

Summary: poor incision healing is a common complication after abdominal surgery, mainly manifested as incision dehiscence, subcutaneous fat liquefaction, malnutrition, and incision infection. poor healing of the incision will increase the patient's pain and prolong the patient's hospital stay, and the choice of wound treatment is closely related to the wound healing effect. mesenchymal stem cells mainly rely on paracrine effects to exert their therapeutic effects and obtain better therapeutic effects in wound healing. here, the pleiotropic factors secreted from mesenchymal stem cells (mscs-pfs) will be used to treat patients with poor healing after surgery to evaluate its effectiveness and safety.


Eligibility criteria:
inclusion criteria: 1. wound size \<10x10cm2, the wound base only involves subcutaneous and muscle tissue； 2. underwent surgical treatment, all incisions were type i, and the incisions healed poorly and delayed healing after 1 week； 3. there is inflammatory reaction at the incision, but no clear indication of infection, or severe infection of the incision.after debridement and dressing change, the infection is controlled and the fresh granulation period is entered 4. men or women older than 17 years old and younger than 75 years old; 5. psychologically stable, able to complete the test process. exclusion criteria: 1. wound size\>10x10cm2, the wound base is as deep as the chest and abdominal cavity, causing infection or osteomyelitis in the chest and abdominal cavity; 2. surgical incision with purulent infection, local purulent secretions can be seen; 3. those with obvious body temperature and white blood cell elevation, local purulent secretions have positive bacterial culture; 4. patients with diabetes; 5. glucocorticoid users; 6. patients with immune dermatosis; 7. neoplastic wounds, such as wounds after skin cancer resection, or skin wounds caused by tumor invasion; 8. psycho-psychological disorders and poor compliance.
red clover and lifestyle changes to contrast menopausal symptoms in premenopausal breast cancer patients given tamoxifen

Conditions: Breast Cancer

Summary: a prospective double-blind randomized trial of red clover extract (promensil) vs placebo in surgically-treated premenopausal women with estrogen receptor-positive breast cancer taking tamoxifen

premenopausal women with er-positive breast cancer treated by surgery and receiving postoperative tamoxifen with or without lhrh analogues, who may have received pre or postoperative chemotherapy, or immunotherapy (for her2-positive disease), are recruited to a double-blind randomized clinical trial, to receive either a dry extract of red clover (promensil) as one tablet/day orally containing 80 mg isoflavones (treatment group), or one oral tablet/day without active principle (placebo group) for 24 months. all patients receive a diet-lifestyle intervention involving meetings with a dietician (physician) scheduled once a month for the first 6 months, and every 3 months thereafter. the dietician encourages patients to adhere to a macronutrient-balanced, low glycaemic load mediterranean-type diet with personalized recommendations to increase intakes of unrefined cereals, pulses, vegetables, unrefined vegetable fats (e.g. olive oil, nuts, oil-containing seeds), and fish, and reduce intake of high-glycaemic-index foods and saturated animal fats. patients are also encouraged to undertake regular physical activity. outcomes are menopausal rating score (mrs), body mass index (bmi), waist and hip girth, insulin resistance, and levels of cholesterol, triglycerides, and sex hormones. the safety of the red clover preparation is assessed by pelvic ultrasound and mammograms for endometrial thickness and breast density, and by evaluation of the effects of the serum from treated and placebo patients on er-positive bc cell lines.

Eligibility criteria:
inclusion criteria: * histologically confirmed operable er-positive breast cancer * can be ductal carcinoma in situ (dcis) * absence of locoregional relapse or distant metastasis * normal ovarian function * menopause rating score \> or equal to 8 * signed informed consent to participate exclusion criteria: * menopause rating score \<8 * menopausal at diagnosis or at surgery * previous malignancies other than in situ cervical carcinoma or non-melanoma skin cancer * breast cancer recurrence * metastatic breast cancer * non-epithelial breast cancer at histological examination * in situ lobular breast cancer * participation in other randomized clinical trials that could interfere with current study * living distant from center and unable to attend for check-ups and meetings.
sham controlled study of renal denervation for subjects with uncontrolled hypertension

Conditions: Hypertension

Summary: to demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.

this study is a sham controlled, double blind study of subjects with uncontrolled hypertension consisting of two arms, sham and therapy. bilateral renal denervation will be performed non-invasively using the kona medical surround sound system which delivers focused ultrasound therapy to ablate the nerves surrounding the renal artery utilizing real time ultrasound for targeting and tracking.

Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years of age and no more than 90 years of age 2. average sbp ≥ 160 mmhg 3. 24 hour average abpm daytime sbp ≥ 135 mmhg. 4. no medication changes for a minimum of 1 months prior to screening. 5. at minimum, subject must be on at least three antihypertensive medications, with one being a diuretic, and each must meet one or more of the following full dose criteria: 1. highest labeled dose according to medication's labeling; 2. highest usual dose per clinical guidelines jnc-7; 3. highest tolerated dose; and/or 4. highest appropriate dose for the subject per the pi's clinical judgment. 6. subject has two functioning kidneys. 7. subject has an egfr value of ≥ 30 ml/min/1.73 m² (mdrd formula). exclusion criteria: 1. subject has any secondary cause of hypertension 2. subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and doppler analysis on ultrasound 3. subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment 4. subject has a history of intra-abdominal surgery within the past six months 5. subject has heterogeneities in the kidney such as large cysts or tumors that are determined at discretion of the investigator to potentially interfere with treatment. 6. stenotic valvular heart disease for which bp reduction would be hazardous as determined by referring physician. 7. mi, unstable angina, or cva in the prior 6 months. 8. known severe primary pulmonary htn 9. subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months. 10. subject has hemodynamically significant valvular heart disease. 11. subject has bmi over 40 km/m\^2 12. subject has a target treatment depth over 13 cm. 13. subject has anatomy that precludes treatment with the kona medical surround sound system. 14. subject is pregnant, nursing, or intends to become pregnant during the trial period. 15. subject is currently enrolled in other potentially confounding research. 16. subject has any condition that, at the discretion of the investigator, would preclude participation in the trial. 17. subject is unable, or unwilling, to comply with the protocol-required follow-up schedule

Keywords: hypertension renal denervation
a study of the safety and tolerance of three doses of g17dt in metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of g17dt for the treatment of patients with colorectal cancer.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum. * recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy. * life expectancy greater than 3 months. * karnofsky index score greater than or equal to 50%. * written informed consent obtained. exclusion criteria: * neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through stage i. * acute intercurrent illness. * patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results. * patients who had received any other anticancer therapy within 3 months. * factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with h2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery. * patients immunologically compromised including those on corticosteroid therapy. * women of child-bearing age. * positive immediate hypersensitivity reaction to skin testing with study medication. * patients unable to complete the diary book * haematogical status haemoglobin count less than 10g/dl white blood cell count less than 4.0 x 10\^9/l platelet count less than 100 x 10\^9/l
multifocal neuromodulation in motor and cognitive function of people with parkinson's disease

Conditions: Parkinson Disease

Summary: people with parkinson's disease (pd) experience various motor and nonmotor symptoms throughout its evolution. it is characterized mainly by the presence of tremor, stiffness, bradykinesia and postural instability, leading to progressive functional limitation and impairment in the performance of usual activities of daily living. in addition, patients may have cognitive disorders, memory deficits, problems related to visuospatial dysfunction, difficulties in performing sequential or repetitive movements, freezing, and slow psychological responses. previous studies analyzed by systematic reviews suggest the efficacy of transcranial direct current stimulation (tdcs) to improve the motor and non-motor symptoms of pd, depending on the area of stimulation. however, most of these focus only on one specific area. therefore, the overall objective of this study is to investigate the effects of multifocal neuromodulation on the motor and cognitive function of people with parkinson's disease.

for this, a randomized, triple-blind clinical trial will be conducted with 60 people with pd, recruited from the reference centers in neurology and physiotherapy in joão pessoa. after recruitment of participants, they will be randomized into three groups: group 1 - tdcs over primary motor cortex (m1) + dorsolateral prefrontal cortex (dlpfc); group 2 - tdcs over primary motor cortex + frontal polar area (fpa); group 3 - tdcs over primary motor cortex. in each condition, an initial baseline assessment (t0) will be performed after 15 treatment sessions (t1) and 30 days after the end of the protocol (follow-up assessment - t2), during which time participants will not receive any type of treatment. the outcomes evaluated will be: motor and cognitive function, executive functions, attention and planning, balance, gait speed an quality of life. for all analyzes, the statistical software spss (spss inc, chicago il, usa) for windows, version 20.0, will be used and considered significant, an alpha value of 5% (p \<0.05 ).

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pd, issued by a neurologist specializing in movement disorders; * disease staging between i and iii, according to the modified hoehn and yahr scale; * be using antiparkinsonian medication regularly; * score higher than 24 or 18 (for participants with low education), verified through the mini mental state examination. exclusion criteria: * diagnosis of atypical parkinsonism; * neurological comorbidities; * history of epilepsy, neurosurgery (including metal clip implantation) and pacemaker implantation; * previous surgical intervention for pd (dbs implantation - deep brain stimulation); * presence of severe freezing episodes.
manchester antenatal vascular service

Conditions: Vascular Disease

Summary: 25-30% of women with preexisting vascular disease (chronic hypertension/diabetes/obesity) will develop pre-eclampsia and or growth restriction. in addition, the frequency of stillbirths in this group is dramatically increased over the general population. pregnancy complications in this very heterogeneous group are likely to be a combination of a failure of the maternal vasculature to adapt to pregnancy and/or a failure of placental development. the relative contribution of these two mechanisms is poorly understood and current preventative strategies (aspirin) in this group only prevent a small number of adverse outcomes. this important and complex group have been inadequately investigated to date mainly because of the diversity of their underlying disease complicating prospective research studies. the evolution of tools which allow more detailed assessments of both uteroplacental blood flow and maternal vascular function will enable us to perform prospective studies in these women and to develop targeted preventative measures. recent biomarker studies have also identified a number of biomarkers which have not yet been assessed in these high risk groups.


Eligibility criteria:
inclusion criteria: women with preexisting vascular disease: 1. chronic hypertension bp ≥140/90 at ≤14 weeks 2. chronic hypertension requiring antihypertensive treatment ≤ 14 weeks 3. pre gestational diabetes with evidence of vascular complications (hypertension, nephropathy) 4. history of ischemic heart disease 5. previous early onset pre-eclampsia (delivery \< 32 weeks) 6. obesity (bmi ≥ 40) with any history of hypertension or booking bp≥130/80 exclusion criteria: women who do not meet the inclusion criteria

Keywords: vascular disease pregnancy chronic hypertension diabetes obesity
a study of abemaciclib (ly2835219) in combination with fulvestrant compared to chemotherapy in women with hr positive, her2 negative metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (hr+), human epidermal growth factor receptor 2-negative (her2-) metastatic breast cancer that has spread to internal organs. your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.


Eligibility criteria:
inclusion criteria: * participants must be females of post-menopausal status with hr+, her2- breast cancer that has spread to internal organs * participants must have had at least one endocrine therapy * participants must be willing to use a device to answer daily questions about how they are doing for the duration of their participation in the study * if participant has diarrhea from a previous treatment, they should talk to their doctor to ensure they have recovered enough to participate in this study exclusion criteria: * participants must not have breast cancer that has spread to the brain if untreated and with symptoms * participants must not have had any systemic treatment after their breast cancer has spread unless it is endocrine therapy * participants must not have certain active infections including hiv or hepatitis * participants must not be pregnant or breastfeeding * participants must not have certain types of cancers or certain previous cancer treatments * participants must not have certain serious medical conditions, including heart or lung disease, or have had certain types of tissue or organ transplants